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Clarithromycin 500 Mg Film-Coated Tablets

Document: leaflet MAH GENERIC_PL 11311-0500 change

PATIENT INFORMATION LEAFLET

Clarithromycin 250 / 500 mg film-coated tablets

(Clarithromycin)

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, please ask your doctor or your pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor


or pharmacist.

In this leaflet:

J What Clarithromycin is and what it is used for

4

Possible side effects

^ Before you take Clarithromycin

5

How to store Clarithromycin

^ How to take Clarithromycin

6

Further information


What Clarithromycin is and what it is used for

Clarithromycin is an antibiotic which belongs to the group of macrolide antibiotics. It stops the growth of certain bacteria.

Clarithromycin is used in treatment of infections caused by bacteria which are sensitive to clarithromycin, for example:

■    In the bronchi and lungs

■    In the sinuses and throat

■    On the skin and in the muscles

■    For gastric ulcers caused by the bacterium Helicobacter pylori

|2 Before you take Clarithromycin

Do not take Clarithromycin

■    if you are allergic (hypersensitive) to clarithromycin, other macrolide antibiotics or to any of the other ingredients of Clarithromycin

■    if your blood potassium level is low

■    if you are taking

-    ergot derivatives (medicine to treat migraine)

-    cisapride (gastric medicine)

-    pimozide (antipsychotic)

-    terfenadine or

-    astemizole (antiallergics)

Take special care with Clarithromycin

Tell your doctor before taking this medicine

■    if you have reduced liver or kidney function

■    if you are allergic to lincomycin or clindamycin

(antibiotics)

■    if you have, or have had, heart problems or

■    if your blood potassium and magnesium level have previously been low

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Certain other medicines may affect the effectiveness of Clarithromycin or vice-versa. Such medicines include:

Clarithromycin may increase the effect of the following medicines:

■    Terfenadine (antiallergic), pimozide (antipsychotic), cisapride (gastric medicine), ergot alkaloids (migraine medicine) (see "Do not take Clarithromycin")

■    Alprazolam, triazolam, midazolam (hypnotics)

■    Digoxin (heart medicine), theophylline (antiasthmatic), warfarin (blood thinning medicine)

■    Lovastatin, simvastatin, cerivastatin,atorvastatin (cholesterol lowering agents)

■    Cyclosporine, sirolimus, tacrolimus (immunosuppressants)

If your doctor has specifically recommended to take Clarithromycin and any of the above mentioned medicines at the same time, your doctor may need to monitor you more closely.

The following medicines may weaken the effect of Clarithromycin:

■    Rifampicin, rifabutin (antibiotics)

■    Efavirenz (antiviral)

■    Phenytoin, carbamazepine, phenobarbitone (antiepileptic)

■    St John's Wort Please note:

   Ritonavir (antiviral) may increase the effect of Clarithromycin

■    Clarithromycin may weaken the effect of zidovudine (antiviral). In order to avoid this you should leave a 1-2 hour interval between taking these medicines

■    The use of Clarithromycin at the same time as quinidine or disopyramide (heart medicine), astemizole (antiallergic) or other macrolide antibiotics may cause cardiac arrhythmia

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant or breast-feeding do not take Clarithromycin 250 mg before consulting your doctor.

Driving and using machines

Clarithromycin has generally no effect on the ability to drive or use machines. However, when side effects occur, such as dizziness, confusion and disorientation, the ability to drive or use machines may be reduced. Use caution when driving and operating machinery until you're aware of how this medicine affects you.

Important information about some of the ingredients of Clarithromycin

This medicine contains lactose. If you have been told by doctor that you have an intolerance to some sugars, contact your doctor before taking Clarithromycin.

How to take Clarithromycin

The doctor will prescribe the individual dosage which is appropriate for you. It is important that you take your medicine precisely in accordance with the doctor's instructions. You should check with your doctor or pharmacist if you are not sure.

Dosage

The usual dose is:

Adults and adolescents (12 to 18 years)

Clarithromycin 250 mg film-coated tablets:

1    Clarithromycin 250 mg film-coated tablet twice daily.

The dosage may be increased to 2 Clarithromycin 250 mg film-coated tablets twice daily.

Clarithromycin 500 mg film-coated tablets:

V Clarithromycin 500 mg film-coated tablet twice daily.

The dosage may be increased to 1 Clarithromycin 500 mg film-coated tablet twice daily.

Gastric ulcer caused by the bacterium Helicobacter pylori

2    Clarithromycin 250 mg film-coated tablets twice daily or 1 Clarithromycin 500 mg film-coated tablet twice daily in combination with suitable antibiotics and medicines which are used for the treatment of excess gastric acid production.

Children (younger than 12 years):

Use for children under the age of 12 years (under 30 kg bodyweight) is not recommended.

For these patients other pharmaceutical forms e.g. suspensions are available.

continued....

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